Ultrasonic probe with positioning device for examination devices and operation devices

ABSTRACT

An ultrasonic probe with an ultrasonic head (K), which is arranged on or in a shaft (S) and is moveable with or in this shaft, and a positioning apparatus (P) for at least one examination or operating device is described, which is connected with the shaft. Also, medical operating apparatuses with examination probes and uses of the ultrasonic probe and the medical implements are described.

RELATED APPLICATIONS

This application is a U.S. national stage of PCT InternationalApplication Number PCT/EP01/13535, filed Nov. 21, 2001, claimingpriority from German Patent Application No.DE 100 58 370.9, filed Nov.24, 2000, and German Patent Application No.DE 101 34 911.4, filed Jul.18, 2001,

The invention relates to a positioning apparatus for insertion andpositioning of an ultrasonic probe and a further examination ortreatment device in an organism to be analyzed, and in particular, anendoluminal ultrasonic probe, which is equipped with a positioningapparatus, which is particularly equipped for guiding and positioning ofa further examination or operating device in the body of the organism.The invention also relates to a method for arranging and/or actuation ofexamination or operating devices in the body and applications ofexamination probes, in particular, an endoluminal ultrasonic probe witha positioning apparatus.

Modern ultrasound apparatuses provide an important contribution fordiagnostics that provide images and make possible a fast, painless, andsafe analysis of organs and anatomical and pathological structures. Inaddition, sonographic technologies have been developed, with whoseassistance it is possible to take ultrasound-specific biopsies oraspirate from organs or body cavities.

Since the beginning of the eighties, the first puncture aids forultrasonic probes already have been described (see, for example, U.S.Pat. Nos. 4,363,326, 4,402,324, 4,489,730, 4,542,747, and 4,635,644).These devices operate as simple puncture guides for ultrasonic probes,with which biopsies specified by ultrasound can be taken from the bodystarting from the body surface. Also, puncture guides are known, whichon one side, are fixedly integrated in the ultrasonic probe (U.S. Pat.Nos. 4,363,326 and 4,635,644) or are removable (U.S. Pat. No.4,402,324). These removable puncture aids have different forms. Thus,among other things, a wedge-shaped puncture guide has been developed,which fits in a precisely adapted, wedge-shaped transverse recess in theultrasonic probe (U.S. Pat. No. 4,489,730). After the puncture, thepuncture needle can be withdrawn along with the puncture guide from theultrasonic probe, so that the needle can be left in the body of thepatient and the ultrasonic probe can be removed simultaneously. In U.S.Pat. No. 4,542,747, an ultrasonic probe is described, which comprisestwo halves, each with a guide slot. After assembly of the two halves, apuncture channel is formed by the two matched slots. After the puncture,the two ultrasonic probe halves can again be separated from one anotherand removed, so that, again, the needle can be left free in the patient.From U.S. Pat. No. 5,052,396, a removable puncture guide is known, whichhas multiple guide slots for receiving needles with different diameters.

Puncture aids for endoluminal ultrasonic probes are also known. Thus, atransvaginal ultrasound probe is known, on which a puncture guide hasbeen transversely attached, so that with ultrasound selectively, eggcells can be removed from the ovaries or biopsies from the female pelvicorgans (U.S. Pat. No. 4,742,829). For improved representation of thepuncture needle in the ultrasonic image, in addition to normalsonographic technology, also a vibration system has been developed,which excite the puncture needle in subtle oscillations, whereby theneedle, based on the Doppler effect, can be better illustrated (U.S.Pat. No. 5,343,865). In addition, also flexible endoluminal ultrasonicprobes with a working channel are known, which are not impaired bybending of the ultrasonic probe (U.S. Pat. No. 5,469,853). With thissystem, biopsies in the frame of endosurgical instruments can be taken.Also surgical instruments are used, with which the tissue to be treatedcan be analyzed in advance before the incision or coagulation with thesonic head of the apparatus.

In the last years, the described types of puncture aids have beenfurther simplified and improved. Thus, shell-shaped guides are known,which only insignificantly enlarge the diameter of the ultrasonic probe(U.S. Pat. No. 5,924,992). In addition, retaining systems of thepuncture guides are known, which make possible a removal of the insertedneedle from the sonic probe with endoluminal ultrasonic probes, so thatthe ultrasonic probes can be removed and the puncture channel can beleft in the patient (U.S. Pat. No. 6,095,981).

The conventional ultrasonic probes with puncture aids have a series ofdisadvantages. The function of the known arrangements is limited, inthat the distance of an inserted diagnostic or operating device (forexample, a needle) from the sonic head is fixed and can neither bechanged or exactly controlled in the ultrasonic image. None of thedescribed puncture systems for ultrasonic probes is controllable, suchthat the distance from the inserted implement to the sonic head with thepredetermined position of the endoluminal sonic probe in the patientscan be manipulated. Therefore, with the present ultrasonic probes andthe puncture systems connected with them, it is impossible to placecatheters, puncture needles, or other examination or operating devicesspecified with the aid of an endoluminal sonic probe and at variabledistance from the sonic head in the surrounding tissue of vessels ornarrow hollow organs. This is true because the position of theultrasonic probe would have to be manipulated, such that the holloworgan or the vessel in which the probe is located would be harmed (forexample, ripped, torn, pinched, perforated), or because thismanipulation is very inhibited by the structure of the surroundingenvironment. An endoluminal ultrasonic probe can be shifted in this caseonly in the longitudinal axis or rotated about this axis.

With the ultrasonic probes with the puncture aids described in the priorart, the accurate puncture of a structure, which is located transverselyin a wall region of a narrow lumen (for example, the urethra or a bloodvessel), is not possible, due to the lack of changeability of the exitangle of the diagnostic or operating device from the puncture device. Inaddition, the puncture guides up to this point cannot be selectivelyshifted along the shaft of the endoluminal sonic probe. Thesedisadvantages are also true for common endoluminal MRI probes.

It is further generally known that the inspection of the urethra and theinjection of fillers (“bulking agents”) until now take placepredominately with the aid of endoscopes. In order to avoid damage uponinsertion of the endoscope (in particular, the mucous lining and thelayers lying there under), endoscopes of this type are generallyequipped with a perfusion channel, which discharges on the front side ofthe endoscope. By means of the continual flushing of the urethra withfluid, the urethra is widened in front of the endoscope lens. In thismanner, the endoscope can be inserted, without perforating the urethrawall. The progression and the lumen of the urethra are visible by thewidening before the endoscope in its course. At the same time, byapplication of liquid in the urethra during the therapy, the therapyresult can be determined.

Common constructions of transluminal ultrasonic probes are useable forthe application of bulking agents in the urethra in a restricted manneronly, since upon insertion of the probe in the urethra by unpracticedoperators, injuries can occur. With transurethral sonic probes with onlyone sonic plane (that is, probes which only provide the representationof the transverse (cross sectional) image of the tube), therefore,frequently, an endoscope device also is necessary for the risk-freeinsertion of the probe into the urethra.

By the introduction of a second sonic plane in the sonic head of atransluminal sonic probe, in addition to the detection of the crosssection of the urethra, a longitudinal sectional image of the urethra isproduced and therewith, the longitudinal representation of the urethra(that is, in its longitudinal progression) with an endoluminal sonicprobe is possible. These types of probes, however, have the disadvantagethat upon insertion into the lumen, it lies directly on the urethra onits inner wall and the operator is unable to see the longitudinal viewin the lumen of the urethra. Since the urethra is not filled with fluid,serious injuries can take place upon insertion of the probe (inparticular, with men).

With trans-rectal sonic probes, balloon constructions in the vicinity ofthe sonic head are known, which are filled for widening of the rectum,whereby access into the lumen is improved. These embodiments oftransluminal probes are not suited for analysis of particularly narrowurethras, however, since they do not have a perfusion channel forwidening of the lumen by a spraying process of the channel.

A further disadvantage of conventional constructions of ultrasonicprobes with manipulators is their complicated structures. Conventionalmanipulators are equipped with a micro-mechanism, and therefore, areexpensive and complex to manufacture. A one-way use is not practicalwith micro-mechanical manipulators.

Also, flexible ultrasonic probes and endoscope devices are known, whichare equipped with deflecting devices. A conventional deflecting device,for example, is made available by a linkage, which is integrated in theprobe shaft and with its help, the ultrasound head can be deflected.

The object of the present invention is to provide an improved ultrasonicprobe with a positioning device, with which the disadvantages of theconventional arrangements can be overcome and which, in particular, hasa broadened application range. With the present invention, inparticular, a precise monitoring of the positioning of the diagnostic oroperating devices in the body of an organism should be possible. Afurther object of the invention is the provision of a positioningdevice, which is suited for the insertion and positioning of examinationprobes in organisms. The object of the invention is also to makeavailable novel methods for positioning of diagnostic and operatingdevices and for application of diagnostic or operating devices.

The basic idea of the invention is to provide a positioning apparatusfor at least one examination and operating device at an ultrasonic probewith an ultrasonic head, which is attached on a flexible or rigid shaftand is moveable with this shaft, whereby the positioning apparatus hasat least one puncture guide, which forms a guide with a defined mountingor a stop for the examination or operating device, and the examinationand operating device is displaceable with a deflecting device, such thatthe stop (or a lumen of the puncture guide, an exit opening of thelumen, or the examination or operating device inserted in the lumen inan operating state) has a predetermined, or temporally changeable,position relative to the ultrasonic head. The ultrasonic probepreferably is an endoluminal ultrasonic probe. The examination oroperating device (below: manipulation device) is, for example, a biopsydevice, an injection pipette, or a surgical apparatus.

The ultrasonic probe of the present invention has the advantage that thepositioning apparatus for the manipulation device simultaneously forms adefined mounting and makes possible a flexible adjustability(displaceability, angle adjustment) into predetermined positions.

With the ultrasonic probe with a flexible puncture aid, for the firsttime it is possible to selectively change the distance between the sonichead and the inserted manipulation device, which, for example, exitstransversely to the ultrasonic probe from the guide device. Thischaracteristic brings different advantages, in particular, with use inhollow organs, vessels, joints, other body cavities or narrow operatingareas, in which the ultrasonic probe practically can be rotated,displaced forward, or displaced backward only. By the application of anendoluminal ultrasonic probe with a flexible puncture aid, the positionof the operating or diagnostic device (for example, a catheter) can bechanged selectively for the first time during the examination oroperation.

According to a preferred embodiment of the invention, the deflectingdevice for the at least one manipulating device is adjustable with acontrol device. The deflecting device is driven, such that the stop ofthe puncture guide or the inserted manipulation device has apredetermined position relative to the ultrasonic head or is moved alonga predetermined distance relative to the ultrasonic head. The positionis represented by predetermined spatial coordinates relative to theultrasonic head. The control device preferably is connected with theimage-generating system of the ultrasonic probe via a coordinategenerator. This contains, in particular, a display screen for displayingultrasonic images. According to the present invention, it is providedthat with the coordinate transmitter of the control device, signalscorresponding to the adjusted relative coordinates of the puncture guideare transferred to the image-generating system and are used fordisplaying a marking, for example, a puncture aid line or a puncture aidpoint, on the display device.

One subject of the invention, therefore, is also ultrasonic probes withan image-generating system, which is connected with the control deviceof a puncture guide and is arranged for indicating the position of thepuncture guide or the manipulation device inserted in the puncture guideon a display device, and a method for controlling a positioning deviceof an ultrasonic probe, in which the actual orientation and/or movementof a positioning device relative to the ultrasonic head is imaged on thedisplay device of the image-generating system.

The puncture aid marking on the display device (for example, a punctureaid line or a puncture aid point) offers the possibility that before theexit of the manipulation device or implement from the working channel(lumen) of the puncture guide the exact end position in the ultrasoundimage can be calculated, and the puncture, for example, along thecalculated puncture aid line in the ultrasound image, also can bemonitored. After the advancement of the respective implement, itsposition can be controlled actually in a real-time ultrasound image andthe application can be monitored. In addition to mono- or biplanarstandard ultrasonic probes, also new ultrasonic technologies can beused, such as, for example, 3D-sonography or color Doppler sonography.With the assistance of various diagnostic- or operating devices, amongother things, biopsies can be taken, medications, solutions or cellsuspensions can be injected, via various working probes, energy applied,or surgical apparatus can be inserted and selectively placed andactuated.

According to a further embodiment of the invention, an endoluminalultrasonic probe is provided, which with the diagnostic or operatingdevice runs in the ultrasonic probe and through the ultrasonic head, sothat with the assistance of the deflecting device the ultrasonic headand the diagnostic or operating device can simultaneously be selectivelydeflected. These variations represent an important advancement,especially with laparoscopic ultrasound probes.

The position of a manipulation device, which can be inserted in thepuncture guide, can be calculated before the exit from the punctureguide. The calculable position of the manipulation device after exitfrom the puncture guide is displayed in an ultrasonic image with thehelp of a puncture aid line or a puncture aid point. With the assistanceof the coordinate transmitter, the puncture aid line or puncture aidpoint can be changed simultaneously with the deflecting or manipulationdevice and its position can be selected in a coordinated manner.

By means of the controllable deflecting device of the puncture guide ofthe ultrasonic probe, injection needles, for example, can be placed veryprecisely in hollow organs, vessels, joints, and body cavities. In thismanner, for the first time, an exact and controllable injection ofmedications, cells, or therapeutic substances into the body of thepatient is possible, whereby the location of the application of theexamination or operating device can be changed and before the actualcontact, can be exactly planned and selected. With this ultrasonicprobe, all types of examination or operating devices can be insertedinto the body of the patient ultrasound-specific through a working lumenof the puncture device, whereby this technology has all the advantagesof minimally invasive surgery.

According to a further embodiment of the invention, an endoluminalultrasonic probe with a biplanar standard ultrasonic probe is provided,which, in addition to the above-described injection devices, has aperfusion channel or a removable perfusion catheter. With thisembodiment, the detection of longitudinal sonic images is made possibleadvantageously.

According to a further embodiment, an ultrasonic probe according to thepresent invention is equipped with a pressure sensor. Such anendoluminal sonic probe permits not only the ultrasonic-specificinjection of bulking agents into the wall, for example, of the urethra,but also the control of the urethra pressure profile (and therewith, thetherapy result) with the same device during the therapy. The pressuresensor includes, for example, a known pressure measuring apparatus (forexample, with a membrane, which upon pressure changes, is deflected andtransfers pressure changes, for example, via a fluid column to atransmitter), with which a pressure profile in a lumen, for example, theurethra, can be determined.

With the present invention, also a medical implement is made available,which forms a positioning apparatus for examination probes and furtherexamination or manipulation devices. The positioning apparatus has acylindrical working channel, preferably with an inner diameter in therange of 1 mm to 7 mm, for accommodating at least one examination probe(for example, an ultrasonic probe, endoscope device, and/or MRI probe).In the wall of the working channel, at least one further working channelis provided, in which the additional examination or treatment device canbe inserted. The additional working channel also can be provided in anadditional attachment sleeve that can be attached to the cylindricalworking channel. The attachment sleeve also can support the deflectingdevice for the examination probe or the manipulation or examinationdevice. The attachment sleeve, which forms a displaceable manipulationdevice, can be attached from the outside onto an endoscope, azystoscope, or another examination apparatus.

In contrast to conventional medical implements, therefore, multiplefunctional advantages are achieved. First, the attachment sleeve withthe manipulation device can be easily manufactured (for example, in aninjection molding method). Second, the attachment sleeve can beexchanged as a one-way material after each use. Finally, a perfusionchannel or catheter can be provided in the attachment sleeve, which is adirect part of the one-way article. The sterility of the medicalimplement is improved in comparison with conventional devices, in whichthe perfusion channel runs in the interior and after each use, must besterilized.

A subject of the present invention is also a method for analysis and/ortreatment of tissue or organs with the ultrasonic probe of the presentinvention. This can take place with or without use of the puncture aidmarking on the display device.

According to a preferred embodiment of the method of the presentinvention, the ultrasonic probe is positioned first according to theapplication on or in the tissue or organ of interest. Next, an actuationof the positioning apparatus takes place, such that the puncture guidetakes up predetermined relative coordinates relative to the ultrasonichead. Then, the respective manipulation device (examination or operatingdevice) is inserted into the positioning apparatus and is moved to thestop and actuated in this operating position. In the operating position,possibly a movement of the manipulation device along the puncture aidmarking is provided. This movement is controlled with the controldevice.

Important steps of the method of the present invention for positioningof examination or operating devices are the placement of the probe inthe body with a determination of the tissue to be analyzed or operatedon, the orientation of the positioning apparatus and the insertion andpossibly actuation of the examination or operating device.

The subject matter of the present invention also is a method forinjection of living cells in a carrier medium and/or biomaterials orbiocompatible substances into an organism, whereby the ultrasound probeaccording to the present invention is used.

The invention is described with reference to a probe with an ultrasoundhead; however, it is not limited to this application. Alternatively, theprobe can be equipped with all of the described embodiments with aso-called MRI head, such as is known for magnet resonance formation(MRI, magnetic resonance imaging).

Details and further advantages of the invention are described in thefollowing description with reference to the attached drawings. In thedrawings:

FIGS. 1 through 4 show schematic, partial sectional views of embodimentsof ultrasound probes according to the invention;

FIGS. 5 a, 5 b show schematic illustrations of the display of punctureair markings, according to the invention;

FIGS. 6 through 9 show further partial sectional views of embodiments ofthe ultrasonic probes, according to the invention; and

FIG. 10 shows schematic sectional views of embodiments of medicalimplements, according to the invention.

The invention represents a controllable ultrasound diagnostic andoperating apparatus, with which, for the first time, diagnostic andoperating devices can be inserted ultrasound-specific at a changeableangle relative to the axis of the sonic probe in an ultrasonic head andin a calculable distance from the sonic head in tissue. An essentialadvantage of the construction of the present invention in comparison toapparatuses known until now is that with a predetermined position of theultrasonic probe, a manipulation device inserted in the puncture guidecan be placed in an arbitrarily selectable distance from the sonic headof the ultrasonic probe. The novel puncture guide operates together withat least one deflecting device, which can be manipulated by a controldevice, such that the puncture guide and/or a manipulation deviceinserted in it can be deflected or shifted along the ultrasonic probe.

At the same time, with the assistance of a mathematical calculation, theposition of the manipulation device, which can be inserted in thepuncture guide, can be calculated before exit from the puncture guideand the calculated end position of the manipulation device can berepresented before exit from the puncture guide in the display of theultrasonic image as puncture aid line or puncture aid point. Thus,before the actual contact of the analyzer or operator, the entry angleand the end position of the examination or operating device can bepredicted and can be selected with the control device during thecontact. The application of the examination or operating device (forexample, the insertion of a needle) can be controlled accurately, then,in a real-time ultrasonic image.

The invention is described next with reference to preferred embodiments,in which the ultrasonic probe has an ultrasonic head K, which isattached on the end of a shaft S and with this, is manually moveable,whereby the positioning apparatus P is arranged on or in the shaft S.The realization of the invention is not limited to this form.Alternatively, the positioning apparatus can be arranged with theadjustable puncture guide also directly on the ultrasonic head K or onthe handle G.

In the figures, details of the positioning apparatus and the formationof the puncture aid marking merely are illustrated. The features of anultrasonic probe with a handle, a shaft, and the ultrasonic head areknown as such and therefore are not described likewise like details ofthe image-generating system.

A first embodiment of the ultrasonic probe with the handle G, the shaftS, and the sonic head K is schematically illustrated in FIG. 1. Thepositioning apparatus is mounted on the shaft S and is formed by thepuncture guide F and the deflecting device AV. The puncture guidecontains as a guide a tube- or slot-shaped lumen L, which penetrates thepuncture guide F and the deflecting device AV as a working channel. Inthe deflecting device AV, the working channel is adjustable in itsorientation relative to the probe. The puncture guide F and thedeflecting device AV form a longitudinally extending component, whichruns parallel to the axis of the shaft S. In the deflecting device AV, apredetermined angle of the working channel or lumen relative to theshaft axis is predetermined. The deflecting device AV and the punctureguide F can be displaced selectively with the assistance of the controldevice SV along the shaft S of the sonic probe. In this manner, thedistance of the manipulating device M, which is located in the workinglumen L, from the sonic head K changes. The displacement can take placediscretly or in a continuous arrestable manner. The control device has apin Z in the puncture guide F for discrete arresting in the illustratedembodiment, which precisely fits in one of a plurality of recesses ofthe sonic probe. The puncture guide F is flexible, so that it can beeasily lifted or pivoted away from the shaft and displaced with thedeflecting device and newly positioned. The position of the punctureguide F, the deflecting device AV, and the inserted manipulation deviceM correlates after the engagement of the pin of the puncture guide Fwith the corresponding puncture aid lines or puncture aid points in theultrasonic image of the display device. The manipulation device M runsin the lumen L, which, for example, is a puncture needle or a catheter.

For continual arresting, instead of the pin, a suitable, releasableconnection, for example, a clamping ring, can be provided.

The ultrasonic head K is structured in a known manner and contains,depending on the use, one or more sonic transducers (transducerelements) for sending or receiving ultrasonic waves. The ultrasonic headK can be arranged for generation of uniplanar or biplanar real-timeultrasonic images or of Doppler, color Doppler, or 3D-ultrasonic images.The shaft S comprises a flexible or rigid material, depending on theuse. The puncture guide F is correspondingly at least partially alsoflexible or rigidly formed. In the case of an endoluminal ultrasonicprobe, the ultrasonic head K typically has a diameter of approximately 5to 10 mm. The lumen L in the deflecting device AV has a curved courserelative to the longitudinal axis of the shaft S. The end of the lumen Lfacing toward the ultrasonic head K forms with the shaft axis apredetermined, fixed deflecting angle, through which the slope of themanipulation device M relative to the shaft axis is adjusted. Themovement of the deflecting device AV determined with the control devicetherefore makes possible an adjustment of the manipulation device Mcorresponding to the double arrow.

The puncture guide is fixedly connected with the shaft of the ultrasonicprobe, but can be removed and exchanged.

With the embodiment schematically shown in FIG. 2 of an ultrasonicprobe, according to the invention, with the handle G, the shaft S, andthe ultrasonic head K, the puncture guide F is mounted againtransversely with the lumen L on the shaft S. The deflecting device AVcoincides with the puncture guide F in this embodiment. The controldevice SV is formed by an axial actuator on the shaft S. In order tomake possible an axial movement of the manipulation device Mcorresponding to the double arrow, the puncture guide F can be displacedaxially parallel to the orientation of the shaft axis, so that theinserted manipulation device is also displaced. Therefore, again thedistance of the manipulating device angularly exiting from the punctureguide to the ultrasonic head changes. Depending on the positioning ofthe deflecting device AV, the end of the manipulation device M hasdefined relative coordinates with reference to the ultrasonic head K.

By means of a defined adjustment of the deflecting device AV and/orpuncture guide F, the manipulation device M is adjusted, so that its endhas predetermined relative coordinates with reference to the ultrasonichead. This assumes that the insertion length of the manipulation deviceM is known or definitely adjusted. For adjustment of the insertionlength, preferably a stop (not shown) is provided on the puncture guideor in the deflecting device AV, which cooperates with a correspondingprojection on the manipulation device. The stop also can be provided onthe handle or another part of the ultrasonic probe, or with the use ofmarkings on the manipulation device M, with which the insertion lengthon the ultrasonic probe can be determined, the stop can be completelyomitted.

In particular, when the shaft S is made from a flexible material, theultrasonic head preferably is equipped with a clamping device fortemporary fixing on the tissue to be analyzed. The clamping device, forexample, is formed by a gripper Z actuable by the handle and makes itpossible that the ultrasonic head before insertion of the manipulationdevice into the body is positioned. For fixing, also an inflatableballoon can be provided.

In FIG. 3, an endoluminal ultrasonic probe is schematically illustrated,in which the positioning apparatus contains the puncture guide F withthe lumen L for receiving the manipulation device M and the deflectingdevice AV as separate components. The deflecting device is mounted onthe shaft of the ultrasonic probe or on the sonic head. With the controldevice, the deflecting device is controlled such that the exit angle ofa diagnostic or operating device in the puncture guide is changed afterthe exit from the puncture guide. The deflecting device can be moved inthe longitudinal direction of the sonic probe or also at a right angleto it (see double arrows).

FIG. 4 shows a modified embodiment of the invention, in which thepuncture guide is integrated in the shaft S of the ultrasonic probe. Inthe shaft S, the lumen L of the puncture guide runs near the signallines of the ultrasonic head K. The deflecting device AV is arrangedbetween the shaft S and the ultrasonic head K and is oriented for aninclined and/or axial exit of the manipulating device M. With thecontrol device, the deflecting device AV can be actuated, in order tochange the exit angle or the axial position of the manipulation deviceM.

For actuation of the deflecting device AV in the embodiments shown inFIGS. 1 through 4, either a mechanically, electromechanical,magneto-mechanical, or piezo-electric actuator can be used, or also amanual adjustments can be provided. Such actuators and adjustments aregenerally known, particularly from micro-surgery and laboratorytechnology.

Also, other deflecting devices can be used, which make possible acontrolled and controllable transverse deflection of the manipulationdevice and which are controlled by the control device.

The manipulation device generally is an examination or operating device,such as, for example, a puncture needle, biopsy needle, injectionneedle, a catheter, or a micro-surgical tool. According to aparticularly advantageous embodiment of the invention, the manipulationdevice includes a fluid supply device, a catheter, and an injectionneedle. With this construction, it is possible, with the supply device,to supply a medication, a solution, or a suspension with biological orbiocompatible materials or suspended particles, such as, for example,living cells or implantation materials, via the catheter and theinjection needle ultrasonic-selectively in a predetermined tissue regionor an organ. On the exit end of the lumen, a nozzle being integrated orattached as a component can be provided. The structure of the supplydevice, catheter, and injection needle can be equipped for injection ofmaterial under increased pressure (pressing in of so-called bulkingagents).

A particular advantage of the present invention is that with a relativesimply constructed deflecting device, with which the angle of the lumenis adjusted relative to the shaft, the inserted manipulation device canbe reproducibly oriented. If the manipulation device is made of elasticstainless steel, for example, then this can be bend in the deflectingdevice, however, exits straight from the lumen.

According to a modified embodiment of the invention (not shown),multiple puncture guides can be provided on an ultrasonic probe, whichare arranged for simultaneous guiding and positioning of multiplemanipulation devices and whose position can be changed ultrasonicallycontrolled. For example, multiple deflecting devices can providemultiple tube- or slit-shaped guide lumens on the shaft. Alternatively,these are integrated in the shaft.

The manipulation device can have also a gripper, a clamp, a tweezer, acutter, and/or a knife as a surgical implement. For actuation of themanipulation device, this is connected with an external actuationdevice, if necessary. Also, an additional actuation device of thepuncture guide can be provided, which is arranged for pivoting orshifting of the puncture guide on the shaft of the ultrasonic probe.

According to a further preferred embodiment of the invention, theultrasonic probe is equipped with an endoscopy apparatus. The endoscopyapparatus is adjusted as the manipulation device with the punctureguide. Alternatively, the endoscopy apparatus is provided as a separatecomponent on the ultrasonic probe. Finally, the manipulation deviceitself also can be formed by a probe with an ultrasonic head.

A particular advantage of the invention is that the puncture guide has arelative simple construction. This makes it possible that the handle,the shaft, the ultrasound head and/or the puncture guide aremanufactured entirely or partially as one-way components.

An essential feature of the invention is that the manipulation device ispositioned or moved with the puncture guide in a defined manner relativeto the ultrasonic head. From the adjustment of the puncture guide andthe geometric properties of the manipulation device, the relativecoordinates relative to the ultrasonic head can be used for theinventive display of a puncture aid marking in an image-generatingsystem of the ultrasonic probe. This is illustrated in FIGS. 5 a and 5b.

FIG. 5 a shows a transversal image in a schematic illustration of amonitor M of the image-generating system, which is supplied from theendoluminal ultrasonic probe. In this image, a puncture aid point HP isformed as a puncture aid marking, which is produced from the coordinatetransmitter of the control device for control of the deflecting device.The position of the puncture aid point HP relative to the ultrasonicfield UF is adjusted on the monitor on the basis of position data, whichthe control device supplies corresponding to the actual orientation ofthe positioning apparatus. In this manner, the position of a diagnosticor operating device advanced in the puncture guide already can berecognized in the ultrasonic image before exit from the puncture guideand can be selectively changed. In FIG. 5 b, a puncture aid line HL asthe puncture aid marking is shown in a longitudinal image supplied fromthe ultrasonic probe. Again, the position of a diagnostic or operatingdevice advanced in the puncture guide already can be recognized in theultrasonic image before exit from the puncture guide and can beselectively changed. In addition, the advancement of the diagnostic oroperating device can take place accurately in a real-time ultrasonicimage. The puncture aid line HL also can mark a distance, which wouldcover the manipulation device inserted in the positioning apparatus inan advanced state with a corresponding actuation of the deflectingdevice.

The injection of living cells in a carrier medium and/or biomaterials orbiocompatible substances in an organism, according to the presentinvention, includes the following steps.

The ultrasonic probe is inserted preferably in hollow organs, such as,for example, the gastro-intestinal tract, the urogenital tract, the noseand sinus cavities, airways, joints, body cavities, such as, forexample, abdominal cavity, the chest cavity, the cranium cavity, thepelvic cavity, into a puncture channel, vessel or intra-operatively inan operating area. The insertion takes place alternatively with orwithout an introduced manipulation device, which here is an injectiondevice. Subsequently, the positioning apparatus, if necessary, with theuse of the puncture aid marking, is adjusted and, if necessary, theinjection device is introduced. The injection device is connected with areservoir of the substance to be injected. A preferred application isthe injection of medications, fluids, solutions, suspensions withbiological or biocompatible materials and/or suspensions with livingcells, in particular, with or without carrier materials. A transurethralor transrectal injection for therapy of urinary incontinence or stoolincontinence takes place, for example. In this connection, myoblasts,bulking agents, for example, collagen, pharmacological substances and/orgrowth factors are injected into the cell area of interest. Themyoblasts are used alone or in combination with biocompatible materials(bulking agents) as material implants. The injection is monitored withultrasonic control.

FIG. 6 illustrates a further embodiment of the ultrasonic probeaccording to the present invention, which is equipped with a deflectingdevice AV for a manipulation device M corresponding to one of theabove-described forms and which additionally has a perfusion channel (orperfusion catheter) PK. The components of the ultrasonic probe aredesignated with the same reference numerals as those used in FIGS. 1through 4, so far as they are analogous to the above-name embodiments.The deflecting device AV is modified, such that the driving of themanipulation device M takes place with the use of a gear Z, whichcooperates with a corresponding tooth distance a. The perfusion channelPK runs parallel to the shaft S. The free end of the perfusion channelPK is located in front of or near the ultrasonic head K and is formed,such that a perfusion liquid supplied from an external reservoir (notshown) exits in front of or near the sonic head in the respectiveinvestigated lumen, for example, the urethra in the direction of thebladder, so that the lumen can be rinsed with the perfusion fluid. Withthe perfusion fluid, the lumen is widened in front of the ultrasonichead K. The wall of the lumen, for example, the wall of the urethra,lifts off from the ultrasonic head K. As the ultrasonic head K, abiplanar sonic head is used, which is arranged for receiving ultrasonicimages in two sonic planes. The first sonic plane serves for thetransverse, radially directed observation of the lumen. The second sonicplane serves for the axial observation of the lumen. The second (orlongitudinal) sonic plane makes possible an imaging of the space openedby the perfusion fluid in front of the sonic head. This represents aconsiderable advantage over conventional endoscopic apparatuses. Theprobe can be inserted risk-free into the lumen without use of anadditional endoscope (like the type provided with the embodiment of FIG.7, for example), in particular, into the urethra. The risk of injurywith transurethral sonography is essentially reduced.

The perfusion channel PK is equipped on the opposite end with a valve Vfor connecting a fluid supply. The valve V preferably is actuated suchthat with the endoluminal sonic probe of the invention, the lumen of theurethra is filled with a permanent perfusion rinsing stream. With theembodiment of the ultrasonic probe with the perfusion channel PK, theultrasonic probe represents an ultrasonic zystoscope.

The components “Fix” shown in FIG. 6 represent a fixed fix-unit, whichserves for performing the pull-back technology which is known as such.With the sonic probe of the invention, with the pull-back method, thecross sectional ultrasonic image, upon pulling back (or analogously,upon advancement) of the sonic probe with the assistance of aplanimetric calculation procedure can be added and thus, the entireurethra wall can be reconstructed three-dimensionally. Therefore, ameasuring device with a sensor system (see scaling) is provided, whichdetermines the relative coordinates of the sonic probe with reference toa fixed point Fix, which with the entire analysis is brought into itsfixed position on the patient. With this sensor system, the advancementof the sonic probe into the urethra can be controlled and the relativecoordinates can be transmitted into the calculating unit. From theindividual cross sectional images, then, a three-dimensional model ofthe urethra is computed.

On the free end of the perfusion channel PK, a pressure sensor and/or anelectrode device D is provided. Determining a pressure profile in alumen, for example, the urethra, with a pressure measurer is known assuch. According to the invention, however, this is performed with aparticular advantage with the ultrasonic probe, which is equipped withthe manipulation and, in particular, the injection device. Such anendoluminal sonic probe allows not only the ultrasonic-specificinjection of filling agents into the wall of the urethra, rather alsopermits the control of the urethra pressure profile (and therewith, ofthe therapy results) with the same device during the therapy.

The electrode device includes, for example, a stimulating electrode D,which is localized in the direct area of the sonic head and enables thefield stimulation of muscle fibers in the surrounding environment of theurethra and the determination of contractibility parameters in theultrasonic image. It is known that electrical muscular activity can bemeasured with the assistance of electrodes, which lie on the uppersurface of the fibers (electro-myogram). The transluminal ultrasonicprobe of the invention, which is equipped with such an electrode D,makes possible the determination of electrical muscular activitysimultaneously to the ultrasonic image. Thus, important parameters aboutthe muscular function in the urethra can be obtained, particularly withthe diagnostic of urinary incontinence.

With the assistance of the so-called ultrasonic elastography (seePonnekanti et al in “Ultrasound in Med. Biol.” vol. 21, 1995, pp.533-543, and Varghese et al in “Ultrasound in Med. Biol.”, vol. 21,2000, pp. 533-543), the elasticity or rigidity of the tissue to beanalyzed can be determined. With this method, a mechanical impulse istransmitted to the tissue to be analyzed with the aid of a movementelement. This movement element can be a vibration device in the probe oralso a displacement device, which is connected with a fix point “Fix”,which is independent of the object (patient) to be analyzed. Before andafter the defined mechanical compression of the tissue to be analyzed,parameters for rigidity or elasticity of the tissue are determined fromthe ultrasonic image.

In an advantageous embodiment of the sonic probe, the ultrasonicelastography is used for the diagnosis with urinary incontinence bymeasuring of the elasticity. The sonic probe shown in FIG. 6 isdisplaced in a defined manner with the ultrasonic elastographymeasurement, so that on the urethra wall, defined extension andrelaxation forces are exerted. The reaction of the urethra wall to thesemechanical forces can now be measured by the sonic probe and with theaid of ultrasonic elastography, can be quantified.

A further embodiment of a medical implement of the invention is shown inFIG. 7 in extracts. The implement can be used with particular advantagefor injection of a suspension composition, which is described in thepatent application DE 101 19 522.2 and whose disclosure content isincluded in the present patent application. The implement has a shaftSch with at least two working channels AK1, AK2. In working channel AK1,an ultrasonic probe US with an ultrasonic head K is arranged. Accordingto a preferred embodiment of the invention, the ultrasonic probe US isaxially movable relative to the shaft Sch. A measuring device UP isprovided on the shaft Sch, with which the position of the ultrasonicprobe US in the working channel can be determined relative to the shatSch. The position of the probe is detected, for example, by means ofmarkings on the probe shaft. From the markings, coordinates are derived,which can then be used to combined longitudinal sections of theultrasonic image to spatial images. In the second working channel AK2,an endoscope device E is arranged, on whose body-sided end, for example,an endoscope lens EL is provided for integrated illumination of therespective analyzed or treated tissue. The illumination takes placepreferably over an angle range of 0 to 90°.

On the second working channel AK2 and/or the endoscope direction E, amanipulation device MV for actuation of a tool W is provided. The tool,for example, is a catheter or an injection needle. The actuation of thetool takes place in the above-described manner. The tool W, for example,is an injection needle, the part of the above-described mixing andapplication devices or the fluid supply devices.

The application of the implement according to FIG. 7 takes place, suchthat the implement first is brought into position in the body part to betreated (for example, hollow organ, tissue). With the endoscope deviceE, the tissue to be treated is visually observed. With a control deviceor with the use of ultrasonic control, the tool W is positioned. Next,the application of the suspension composition takes place via the tool Winto the tissue area of interest, whereby the coordinates (inparticular, end coordinates) are determined in the manner describedabove and the progress of the application is monitored with theultrasonic probe US.

Modifications of the structure shown in FIG. 7 are illustrated in FIGS.8 and 9. According to FIG. 8, a shaft Sch with two working channels isprovided, in which, respectively, an ultrasonic probe with a sonic headK and an endoscope device E with an endoscope lens EL are arrangedaxially displaceably (double arrow). On the shaft Sch, an attachmentsleeve H is attached on the outside, which forms a separate componentthat can be separated from the shaft Sch. The attachment sleeve H formsa positioning device P with a deflecting device AV for the tool W, whichis arranged in a punction guide F. In the attachment sleeve, theperfusion channel PK is also arranged. The attachment sleeve extendspreferably over the entire length of the shaft Sch, so that the end ofthe tool W is arranged in the area of the observation field of theexamination devices in the working channels. The positioning apparatus Pis connected releasably with the shaft.

With the use of flexible examination probes, the shaft Sch also can beangled (see FIG. 9). The attachment sleeve H, which preferably comprisesan elastically deformable plastic material, is correspondingly adapted.

FIG. 10 illustrates the arrangement of the attachment sleeve H on theshaft Sch. The attachment sleeve H can surround the shaft Sch partially(FIG. 10 a) or completely (FIGS. 10 b, c). In the first case, thepossibility of a radially transverse attachment of the attachment sleeveH is provided, while in the other cases, an axial shunting is necessary.In the shaft Sch, at least two working channels are provided. Theattachment sleeve H contains the perfusion channel P and the functionalguide F with the tool W. An additional perfusion channel P can also beprovided in the shaft Sch (FIG. 10 c). The attachment sleeve H can beequipped with outwardly open channels, depending on the use, in which atleast one additional perfusion device PV can be inserted. The perfusiondevice PV is provided, in particular, for a radial spraying of the areain the organism, in which the implement is inserted. The perfusiondevice PV forms, for example, a removable catheter, which runs in aU-shaped depression in the attachment sleeve H or also in the shaft ofthe implement.

The attachment sleeve H can be displaced on the shaft Sch and/orrotated, in particular, in order to exactly orient the tool W.

The features of the invention in the foregoing description, in theclaims, and in the drawings can be significant individually as well asalso in combinations for the implementation of the invention in itsvarious embodiments.

1. A positioning apparatus for at least one examination probecomprising: a rigid shaft having at least one working channel forreceiving an examination probe, said rigid shaft having first and secondends and an outer major side surface therebetween and a shaft axis; apuncture guide attached on the outer major side surface of the shaft,the puncture guide having at least one tube-shaped lumen for receivingan examination or operating device; and a deflecting device attached onthe outer major side surface of the shaft, wherein: the lumen extendsthrough the deflecting device, wherein an end of the lumen has a curvedcourse relative to the shaft axis, so that the end of the lumen forms apredetermined deflecting angle with the shaft axis, the lumen and thedeflecting device can be displaced relative to the shaft at apredetermined distance parallel to the shaft axis, and at least one ofthe lumen and the deflecting device is arranged for adjusting theexamination or operating device in a predetermined manner with thedeflecting angle relative to the shaft axis or for displacing theexamination or operating device.
 2. The positioning apparatus accordingto claim 1, in which the shaft contains a flushing perfusion channel,which opens near or in front of the end of the examination probe.
 3. Thepositioning apparatus according to claim 1, wherein the shaft comprisesan attachment sleeve which includes the puncture guide.
 4. Thepositioning apparatus according to claim 3, in which the attachmentsleeve is axially displaceable on the shaft at predetermined distancesor corresponding predetermined coordinate values and is rotatablymounted and contains the deflecting device.
 5. The positioning apparatusaccording to claim 3, in which the attachment sleeve can be attachedtransversely to the shaft.
 6. The positioning apparatus according toclaim 3, in which the attachment sleeve contains a flushing perfusionchannel, which opens near or in front of the end of the examinationprobe.
 7. The positioning apparatus according to claim 1, wherein theexamination probe comprises an ultrasound, MRI, or endoscope probe. 8.The positioning apparatus of claim 1, wherein the lumen extends parallelto the shaft axis within the puncture guide.
 9. The positioningapparatus of claim 1, wherein the deflecting device is formed integrallyas part of the puncture guide.
 10. The positioning apparatus of claim 9,wherein the lumen has first and second ends, both said first and secondends having a curved course relative to the shaft axis.
 11. Apositioning apparatus for at least one examination probe comprising: arigid shaft having at least one working channel for receiving anexamination probe, said rigid shaft having a longitudinal shaft axis,first and second ends and an outer major side surface therebetween; apuncture guide mounted on the outer major side surface of the rigidshaft, the puncture guide having at least one tube-shaped lumen forreceiving an examination or operating device; and a deflecting devicemounted on the outer major side surface of the rigid shaft, wherein: thelumen extends through the deflecting device, wherein an end of the lumenhas a curved course relative to the longitudinal shaft axis, so that theend of the lumen forms a predetermined deflecting angle with thelongitudinal shaft axis such that the end of the lumen is directed awayfrom the shaft axis, the lumen and the deflecting device can bedisplaced relative to the rigid shaft at a predetermined distanceparallel to the longitudinal shaft axis, and at least one of the lumenand the deflecting device is arranged for adjusting the examination oroperating device in a predetermined manner with the deflecting anglerelative to the longitudinal shaft axis or for displacing theexamination or operating device.
 12. The positioning apparatus accordingto claim 11, in which the rigid shaft contains a flushing perfusionchannel, which opens near or in front of the end of the examinationprobe.
 13. The positioning apparatus according to claim 11, wherein therigid shaft comprises an attachment sleeve which includes the punctureguide.
 14. The positioning apparatus according to claim 13, in which theattachment sleeve is axially displaceable on the rigid shaft atpredetermined distances or corresponding predetermined coordinate valuesand is rotatably mounted and contains the deflecting device.
 15. Thepositioning apparatus according to claim 13, in which the attachmentsleeve is attached transversely to the rigid shaft.
 16. The positioningapparatus according to claim 13, in which the attachment sleeve containsa flushing perfusion channel, which opens near or in front of the end ofthe examination probe.
 17. The positioning apparatus according to claim11, wherein the examination probe comprises an ultrasound, MRI, orendoscope probe.
 18. The positioning apparatus according to claim 11,wherein the end of the lumen is within the deflecting device.
 19. Thepositioning apparatus of claim 11, wherein the lumen extends parallel tothe shaft axis within the puncture guide.
 20. The positioning apparatusof claim 11, wherein the deflecting device is formed integrally as partof the puncture guide.
 21. The positioning apparatus of claim 20,wherein the lumen has first and second ends, both said first and secondends having a curved course relative to the shaft axis.